FDA Approvals

Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings

FierceBiotech Aug 26, 2026 FDA Approval

The FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.

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